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Look into these plays instead in this space - $MNMD and $ATAI
Ouch! Down 70% - Clinic Closed!
We have a winner here. Wait until it catches fire :)
Well at least STEV isn't banking at SVB - LMAO!
So glad they don't bank in the US. They will be safe with SVB going down.
(Video) MindMed March 8, 2023 1:30 p.m. ET TD Cowen Health Care Conference
https://wsw.com/webcast/cowen132/mnmd/2007768
MindMed Reports Full Year 2022 Financial Results and Business Highlights
https://mindmed.co/news/press-release/mindmed-reports-full-year-2022-financial-results-and-business-highlights/
– Company positioned for key MM-120 Phase 2b data readout in GAD and Phase 2a data readout in ADHD in late 2023 –
– Company to initiate first clinical trial of MM-402 in 2023 –
– Cash and cash equivalents of $142.1 million at December 31, 2022 –
– Company to host conference call today at 4:30 PM ET –
NEW YORK, March 9, 2023 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the full-year ended December 31, 2022.
“Our significant progress in 2022 has set the stage for what we expect to be a transformational 2023,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder. Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025. I am incredibly proud of our team’s achievements, and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, which we believe will lead to meaningful improvements in patient outcomes in these major areas of unmet medical need.”
Business Update
– The Company reiterates its guidance for its cash runway, which is expected to fund its current operating plan into the first half of 2025.
– MindMed’s management team will participate in the 33rd Annual Oppenheimer Healthcare Conference that is being held virtually from March 13-15, 2023 as well as the 35th Annual Roth Conference in Laguna Niguel, CA from March 12-14, 2023.
– The Company expects to host a virtual analyst and investor day in the first half of 2023. The event will be hosted by the Company’s management team and will include a physician expert and other key opinion leaders.
Recent Highlights and Anticipated Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety disorder (“GAD”) remains on track
– MM-120, the Company’s proprietary, pharmaceutically optimized form of lysergide D-tartrate, is being developed for the treatment of GAD.
– In August 2022, the Company initiated dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD.
– Patient enrollment is currently ongoing, and the study remains on track, with topline results expected to be announced in late 2023.
Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder (“ADHD”) remains on track
– The Company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients.
– The Company expects topline results in late 2023.
Advancing development of MM-402 into first clinical trial in 2023
– The Company is developing MM-402, the Company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), for the treatment of core symptoms of autism spectrum disorder (“ASD”).
– Results from a preclinical study of MM-402 in a model of ASD are expected to be presented in the first half of 2023.
– The Company plans to initiate its first clinical trial of MM-402 in 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD.
– University Hospital Basel (“UHB”) in Switzerland, the Company’s collaborator, is currently enrolling patients in a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers. This trial is comparing the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules.
Collaborations and Partnerships
The Company continues to support its ongoing collaboration with the Liechti Lab at University Hospital Basel (“UHB”) in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with UHB’s research on lysergide and other psychedelic compounds, including data from preclinical studies and investigator-initiated clinical trials.
In September 2022, UHB published the results of a randomized, double-blind, placebo-controlled Phase 2 study in the peer-reviewed scientific journal, Biological Psychiatry. Topline results in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable and beneficial effects of lysergide and its potential to mitigate symptoms of anxiety and depression with an acceptable tolerability profile. The Company believes these results support the continued clinical development of lysergide.
In November 2022, the peer-reviewed publication of a double-blind, placebo-controlled, random-order, two-period crossover investigator-initiated trial of lysergide and ketanserin was published in the International Journal of Neuropsychopharmacology. The study demonstrated the potential of ketanserin to shorten and attenuate the perceptual effects of lysergide.
2022 Financial Results
Cash Balance. As of December 31, 2022, MindMed had cash and cash equivalents totaling $142.1 million compared to $133.5 million as of December 31, 2021. The Company believes its available cash and cash equivalents will be sufficient to fund its operating requirements into the first half of 2025.
Net Cash in Operating Activities. The net cash used in operating activities was $50.1 million for the year ended December 31, 2022, compared to $45.8 million in the year ended December 31, 2021.
Research and Development (R&D). R&D expenses were $36.2 million for the year ended December 31, 2022, compared to $34.8 million for the year ended December 31, 2021, an increase of $1.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for MM-120, and $5.4 million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $5.6 million in expenses related to the Company’s MM-110 program, and a decrease of $2.4 million of expenses in connection with various external R&D collaborations.
General and Administrative (G&A). G&A expenses were $30.2 million for the year ended December 31, 2022, compared to $59.1 million for the year ended December 31, 2021, a decrease of $28.9 million. The decrease was primarily due to a decrease of $27.4 million in non-cash stock-based compensation expenses primarily relating to the modification of stock option awards and RSUs recorded during the year ended December 31, 2021.
Net Loss. Net loss for the year ended December 31, 2022 was $56.8 million, compared to $93.0 million for the same period in 2021.
Conference Call and Webcast Reminder
MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s fiscal year 2022 financial results. Individuals may participate in the live call via telephone by dialing (888) 886-7786 (domestic) or (416) 764-8658 (international) and using conference ID 09516401 or by clicking on this link and requesting a return call. The webcast can be accessed live here on the Financials page in the Investors section of the MindMed website, https://mindmed.co/. The webcast will be archived on the Company’s website for at least 30 days after the conference call.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Lots of action though for simply nothing.
How many times must I say this is over and has been.
What might that be?
Nice bottom here
You got it mick!
Agreed! This will be a popular one.
$SWISF is moving on low volume... Seriously give this one a look.
$SWISF is moving on low volume... Seriously give this one a look.
atai Life Sciences Announces Key Clinical Pipeline and Corporate Updates
Published: Mar 06, 2023
RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophrenia
GRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical development
COMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024
Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash runway, which is now expected into 1H 2026
NEW YORK and BERLIN, March 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, provided key clinical pipeline and corporate updates.
“The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies,” said Florian Brand, CEO and Co-Founder of atai. “Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration.”
Mr. Brand continued, “As part of our efforts to further focus our capital allocation towards generating meaningful clinical readouts in the near-term and to optimize our operational efficiency, we reduced our team by approximately 30%. I am grateful for the dedication of the team members impacted by this decision and their contributions towards our mission.”
Pipeline Updates
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS. Initial results from this study are expected in the 2nd half of 2024.
The phase 2b study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the US-based study is the MATRICS Consensus Cognitive Battery neurocognitive composite score at 6-weeks.
RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
The clinical development plan has been updated to now proceed with a phase 2 study in patients. The updated plan is anticipated to generate the robust clinical data needed to best support potential registration. More details on the clinical development plan will be provided upon initiation of the study.
The updated plan follows the positive results from the phase 1 single and multiple ascending dose study of GRX-917. In this trial, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to leading benzodiazepines, like alprazolam and lorazepam, which are currently considered standard of care. In contrast to these benzodiazepines, however, and based on more than 40 years of the use of etifoxine in clinical practice, etifoxine appears to be non-addictive and does not seem to have the same sedation and other common adverse events. It is believed that etifoxine achieves its anxiolytic activity by increasing endogenous production of brain neurosteroids like allopregnanolone.
PCN-101 (R-Ketamine for Treatment-Resistant Depression)
In January 2023, in conjunction with the phase 2a study results of PCN-101, atai announced it would further evaluate the data and work with its subsidiary Perception Neuroscience (“Perception”) to determine next steps for the program.
atai will continue to support Perception’s development of PCN-101 through the IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.
PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Both depression model studies in rodents and clinical data suggest that R-ketamine could possess more durable effects than S-ketamine despite a lower affinity to the NMDA receptor and potentially a more favorable safety and tolerability profile.
COMP360 (Psilocybin Therapy for Treatment-Resistant Depression)
On February 28th, COMPASS Pathways (“COMPASS”) announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in treatment-resistant depression, with top line data now expected in the summer 2024.
COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support.
Corporate Updates
As part of a strategic review of its pipeline and to enhance operational efficiency and focus, the Company has reduced its workforce by approximately 30%.
The majority of the cost savings will result from a workforce reduction in general and administration and non-clinical development.
The Company has extended its cash runway, which is now expected into 1H 2026.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
Have a good feeling this is going to be a good summer here!
Yes. It's coming! Keep your pants on!
For anyone wondering Panzer hasn't been here in almost 3 months....
Huge mick
Agreed. Accumulating a ton. ;)
"Would" is a past tense adverb of Will... which is the exact power this stock has lost. Would is more akin to Hope...
Not sure if it will help here. No news, no products, no nothing. Sell and move on. Save yourselfs.
This is going to be a good one.
Exactly ;)
Bone.... this isn't going up
There's the death dip I spoke of.
$SWISF moving from floor
Looking ready to run.
What's up with this ticker?
I think ATAI and MNMD are going to be big winners this year.
Big buy end of day. Nice!
This is going to the trips my dudes.
We all know it's coming.
So you're telling me that something is stewing?
The company has barley went up and it's on the expert market. The party hasn't even started yet here.
We shall see.
Coming soon!
Believe what you want. I never mentioned anything about MIKP. I simply casually engaged in conversation. Why does it matter to you what I discussed with someone.
It's not like I had the conversation and then stumbled here to invest.
To each his own.